GENESIS RC AND EON NEUROSTIMULATION SYSTEMS
FDA premarket approval P010032/S025 · decided 2009-01-29
Approval details
- PMA number
- P010032
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GENESIS RC AND EON NEUROSTIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-04-11
- Decision date
- 2009-01-29
- Days to decision
- 293 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR A MOBILE, BATTERY POWERED, CHARGING SYSTEM THAT IS DESIGNED TO CHARGE THE GENESISRC NEUROSTIMULATION (IPG) SYSTEM AND THE EON NEUROSTIMULATION (IPG) SYSTEM.
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